During certain types of medical surgery or treatment, an introducer is used to access the vascular system of a patient. The introducer is inserted through the wall of a blood vessel in order to obtain access to the vascular system and may thereafter be used for guiding medical instruments such as catheters, guide wires and the like.
After completion of the medical procedure, there will be an incision or a wound in the wall of the blood vessel corresponding to the size of the introducer. The bleeding from the wound, which is a result of such a surgical operation, can be stopped by applying direct pressure on the wound. However, applying direct pressure on the wound will require assistance of medical personnel and may also restrict the flow of blood through the vessel. Ischemia may occur and can lead to serious consequences.
In cases of puncturing the femoral arteries, the required time may be as long as about 45 minutes or more and in some cases re-bleeding occurs if the patient is not in rest. Bleeding from a vessel puncture in a substantially sized blood vessel can be severe.
A variety of methods and devices have been suggested for replacing the traditional method disclosed above, some of which involve introducing chemical compounds which act as homeostasis catalysts or as adhering agents, whilst others aim at introducing various forms of plugging members into the puncture.
Sealing devices in form of sealing plugs in the cutaneous channel at the puncture site outside the vessel are known, e.g. from US patent application 2009/0054926 or European patent EP 1349501. However, the blood pressure inside the vessel may press the plug out of position before a reliable sealing has occurred.
Other sealing devices in form of double button type fasteners that are affixed to each other, in the type of an outside member and inside member in relation to the lumen and a crosspiece arranged across the puncture opening, both inside and outside of the vessel wall are known, e.g. from U.S. Pat. No. 7,488,340, or U.S. Pat. No. 7,572,274. The outside member and inside member are brought in a locked configuration upon assembly and compress the vessel wall tissue around the puncture opening.
However, such button type sealing devices may not seal off the puncture optimally.
For instance, such button type devices may restrict the lumen and blood flow therein. The inside member of the device protruding into the blood vessel often substantially restricts the patency of the lumen. This is in particular the case for small diameter lumen, such as at peripheral vessels. A protruding member may also lead to a turbulent flow, which might cause secondary effects, such as creation of thrombosis or embolies.
Furthermore, the devices may damage the vessel wall, in particular in the case of peripheral vessels, such as the arteria subclavia, the arteria axillaris, which for instance are accessed in the region of the clavicle, or the arteria radialis for access in the arm, which all are brittle vessels.
The aforementioned double sided tissue compression of the vessel wall causes a pressure onto the wall tissue, which brings about a number of issues.
For instance, the vessel wall may be damaged when the applied compression or pressure is too high. Necrotic tissue may be built up. The vessel wall may be structurally weakened. The vessel wall may get damaged by the device. A rupture of the vessel wall may occur. As a consequence, a dissection may occur, i.e. a bleeding out of the vessel wall into surrounding tissue of the vessel.
For instance arteriosclerotic vessel are conventionally difficult to seal off. Arteriosclerotic vessels are brittle, conventional sealing devices have difficulties to find hold or damage the brittle vessel wall, the lumen diameter is already reduced and may be further reduced by members of the known sealing devices protruding into the lumen, etc.
When the applied compression or pressure is too low, i.e. the button device is put in place too loose, pressure damages are avoided. However, a leakage may then occur.
Leakage of blood from the puncture site is not desired, and should be avoided.
In particular repeated puncture, e.g. necessary during intensive treatment periods, of such anatomically sensitive vessels, may lead to damage of the vessel.
WO2006/034114 discloses thin film devices implantable within a human subject for occlusion of an aneurysm or body vessel. The devices are movable from an elongated, collapsed configuration for delivery to a deployed configuration within the body. Such an occlusion device includes a thin film mesh attached to a carrying frame. The carrying frame is moveable between a collapsed configuration and an expanded configuration. The thin film mesh can include a plurality of slits, slots and/or pores that typically vary in degree of openness as the carrying frame moves between the collapsed and the expanded configurations. The occlusion device is transluminally positioned within the blood vessel so that the thin film mesh substantially reduces or completely blocks blood flow to a diseased portion of a blood vessel. However, a puncture itself is needed to deploy this device into the vessel as it is not suitable to be delivered itself through an opening to be closed,
US2009/0143815 discloses a device for sealing a puncture opening in a wall of a blood vessel that includes a base frame including a first bi-stable material having a first stable state corresponding to a delivery configuration of the base frame, in which the base frame is retracted to have a relatively smaller overall profile, and a second stable state corresponding to a deployed configuration of the base frame, in which the base frame is extended to have a relatively larger overall profile. The base frame is sized to engage an interior surface of the blood vessel wall when in the deployed configuration. A sealing section is coupled axially as a section to the base frame and includes a second bi-stable material having a first stable state corresponding to an initial configuration of the sealing section, in which the sealing section permits fluid flow, and a second stable state corresponding to a barrier configuration of the sealing section, in which the sealing section prevents fluid flow. The sealing section in the barrier configuration is sized to block fluid flow through the puncture opening when the base frame is in the deployed configuration. However, this device is difficult to deliver as deployment of the base frame is not controllable. Thus, the base frame may expand and engage the vessel wall before the sealing section is correctly positioned. Moreover, this device may migrate along the vessel with too low self expansion pressure of the base frame. The device may also migrate into the vessel wall and damage the latter at too high self expansion force of the base frame. Reliable sealing is thus difficult to achieve with this device. Moreover, a structure as disclosed in US2009/0143815 is traumatic in relation to the vessel wall, in particular at the tissue surrounding the puncture opening.
It is an object of the present invention to provide a novel and inventive device for closure and sealing of a puncture or incision formed in a blood vessel or in other body organs. A further object of the invention is to provide a puncture closure method, in embodiments utilizing the sealing device. The medical arts would benefit from a device that allows for the sealing of blood vessel wall punctures that are created at the termination of a tissue tract that passes through intervening tissues between the vessel wall puncture and a puncture through the skin. It would be preferred if the device was self-securing and small in size so as to be introduced without the need to enlarge the tissue tract beyond the size needed to perform the primary medical procedure.
Hence, an improved medical device or methods for closure of a puncture in a body lumen would be advantageous, and in particular allowing for increased flexibility, and/or patient-friendliness would be advantageous. Advantageously the solution should be atraumatic in relation to the vessel wall, in particular at the tissue surrounding the puncture opening to provide a reliable sealing.